Biotechnology Companies Rush to Develop Treatments for Various Illnesses Found Globally

Wednesday, March 27, 2019 General News
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NEW YORK, March 27, 2019 /PRNewswire/ -- Diseases are commonplace around

the world, especially in regions that don't have access to adequate healthcare. In such underdeveloped regions, diseases such as AIDS, malaria, and tuberculosis ravage countries and their inhabitants. According to the World Health Organization, in third
world countries, people face tens of thousands of deaths daily due to untreated conditions and many of these diseases occur through environmental impacts or purely through hereditary conditions. However, even in developed countries, cases of cancer, heart disease, respiratory disease, and diabetes are growing. The alarming rates have also prompted biotechnology companies to conduct research and development of new treatments in order to effectively combat the growing incidences. According to data compiled by Polaris Market Research, the global biotechnology market was valued at USD 390.1 Billion in 2017 and is projected to reach USD 741.7 Billion by 2026. Furthermore, the market is expected to witness a CAGR of 7.7% during the forecast period from 2019 to 2026. Specifically, the market is expected to be propelled by the growing number of R&D expenditures and the outsourcing activities by both private and government bodies. Moreover, the rising number of future conferences and workshops is also expected to bolster the industry's growth. Pressure BioSciences, Inc. (OTC: PBIO), Bristol-Myers Squibb Company (NYSE: BMY), AstraZeneca PLC (NYSE: AZN), Nektar Therapeutics (NASDAQ: NKTR), Immunomedics, Inc. (NASDAQ: IMMU)

In 2017, biopharmacy applications accounted for approximately 60% of the overall biotechnology market share. The sector itself is expected to continually flourish due to the increased use of bio-recombinant proteins in many of the medications used to treat ailments, as biopharma companies are now focusing on improving customized medicine to further enhance patient recovery. The major difference between biopharmaceutical and pharmaceutical companies is that the former focus on a compound of chemical synthesis which is developed in academic and industrial laboratories, according to Morgan Mckinley. These companies are much more focused on research in order to develop effective treatments. Overall, the growing number of life-threatening medical conditions will further accelerate the overall biotechnology industry's growth. "Biotechnology is a huge part of our everyday lives, from the clothes we wear, the food we eat, the medicine we use to keep us healthy and even the fuel we use to take us around. Biotech already plays, and will continue to play, an invaluable role in meeting our needs. No other industry is better placed to enhance quality of life and respond to society's 'Grand Challenges' of tackling an ageing and ever-increasing population, healthcare and affordability, resource efficiency, food security, climate change and energy shortages," said Jason Johal, Manager at CK Sciences.

Pressure BioSciences, Inc. (OTCQB: PBIO) just announced breaking news this morning that, "the establishment of a Center of Excellence ("CoE") at Dr. Christine Vogel's laboratory at New York University ("NYU")'s Center for Genomics and Systems Biology (the "GSB Center").

As a Center of Excellence, the Vogel Lab will have free use of our primary instrument system, the Barocycler 2320EXTREME (the "2320EXT") until the end of 2020. They will also be offered early access to new, modified, and or improved versions of the 2320EXT and its associated applications during the collaboration period.  Finally, they will have the opportunity to work closely with PBI's science and engineering staff on new developments in all of our various pressure-based technology platforms.

Dr. Vogel, an Associate Professor and internationally-recognized scientist with multiple publications and awards, is an expert in the field of proteomics (the study of proteins), with special emphasis on protein expression patterns and their relationship to human disease – such as cancer.  Dr. Vogel's laboratory uses state-of-the-art equipment and methods to investigate these and other important properties of proteins, and their association with human disease.  As part of the CoE, Dr. Vogel and colleagues, along with students and visitors to the GSB Center, will use PBI's patented pressure cycling technology™ ("PCT") platform to help in the development and validation of protocols for tissue-based protein studies that might eventually be used in a clinical setting.  In addition, the Vogel laboratory will be open by invitation to local, national, and international scientists for workshops and seminars on the use of the PCT platform in the discovery, identification, and elucidation of proteins that may be involved in human disease.

Ms. Roxana McCloskey, PBI's Global Director of Sales and Marketing, said: "Our innovative 2320EXT is based on our patented and enabling PCT platform. The 2320EXT is currently used by research scientists worldwide for the safe, rapid, and reproducible lysis of cells and tissues, to release proteins, DNA, and other important biomolecules for analysis. Such analyses are critical step in the discovery and development of diagnostic, prognostic, and predictive clinical tests used to identify risk, disease presence, or disease progression, and to guide treatment in many diseases, such as cancer."

Professor Vogel commented: "My laboratory uses the most advanced technologies available to investigate the regulation of proteins in different systems in response to environmental stress.  We continually look for powerful, cutting-edge tools to help us reach the highest level of quality possible in our research."

Dr. Bradford Y. Young, Chief Commercial Officer of PBI, said: "We are pleased to have the opportunity to collaborate with Professor Vogel, a well-respected thought leader in proteomics. We believe the 2320EXT has the potential to support and advance the great work that she and her team already have underway at the GSB Center.  We further believe that the added exposure received by the PCT platform at the GSB Center will increase awareness of the benefits of our pressure-based technologies in helping to provide scientists with superior proteomic analyses, which should result in increased instrument sales in 2019 and beyond."

About the NYU Center for Genomics and Systems Biology - The NYU Center for Genomics and Systems Biology is considered by many as a "hub of science" in New York City. It has state-of-the-art "loft laboratories" where scientists including professors, researchers, and students interact to leverage the extraordinary potential of genomics and systems biology in research and education.  This involves the combined skills of genomic, computational, and evolutionary biologists. Faculty also collaborate with researchers in other departments and schools at NYU, such as Physics, Chemistry, Medicine, Engineering, and Global Public Health, as well as with researchers from other major New York institutions and around the world. The intellectual synergisms brought about by these internal and external collaborations, enable us to develop unique approaches to genomics and systems biology.  Working with organisms from all the major branches of the tree of life, researchers at the Center address how genomes encode regulatory genetic networks, respond to changes in the environment or during development, how genes evolve, and how this generates diversity within and across species. These principles are being applied to global questions in human health, food sustainability, bio-energy, and the environment.

About Pressure BioSciences, Inc. - Pressure BioSciences, Inc. (OTCQB: PBIO) is a leader in the development and sale of innovative, broadly enabling, pressure-based solutions for the worldwide life sciences industry. Our products are based on the unique properties of both constant (i.e., static) and alternating (i.e., pressure cycling technology, or PCT) hydrostatic pressure. PCT is a patented enabling technology platform that uses alternating cycles of hydrostatic pressure between ambient and ultra-high levels to safely and reproducibly control bio-molecular interactions (e.g., cell lysis, biomolecule extraction). Our primary focus is in the development of high pressure-based products for biomarker and target discovery, drug design and development, biotherapeutics characterization and quality control, food science, soil & plant biology, forensics, and counter-bioterror applications. Additionally, we are actively expanding the use of our pressure-based technologies in the following areas: (1) the use of our recently acquired protein disaggregation and refolding technology from BaroFold, Inc. to allow entry into the biologics manufacturing and contract research services sector, and (2) the use of our recently-patented, scalable, high-efficiency, pressure-based Ultra Shear Technology (UST™) platform to (i) create stable nanoemulsions of otherwise immiscible fluids (e.g., oils and water) and to (ii) prepare higher quality, homogenized, extended shelf-life or room temperature stable low-acid liquid foods that cannot be effectively preserved using existing non-thermal technologies. For more information, please visit: www.pressurebiosciences.com"

Bristol-Myers Squibb Company (NYSE: BMY) is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. Bristol-Myers Squibb Company and Celgene Corporation (NASDAQ: CELG) recently announced that they have entered into a definitive merger agreement under which Bristol-Myers Squibb will acquire Celgene in a cash and stock transaction with an equity value of approximately USD 74 Billion. Under the terms of the agreement, Celgene shareholders will receive 1.0 Bristol-Myers Squibb share and USD 50.00 in cash for each share of Celgene. Celgene shareholders will also receive one tradeable Contingent Value Right (CVR) for each share of Celgene, which will entitle the holder to receive a payment for the achievement of future regulatory milestones. The Boards of Directors of both companies have approved the combination. The transaction will create a leading focused specialty biopharma company well positioned to address the needs of patients with cancer, inflammatory and immunologic disease and cardiovascular disease through high-value innovative medicines and leading scientific capabilities. With complementary areas of focus, the combined company will operate with global reach and scale, maintaining the speed and agility that is core to each company's strategic approach. Together, the Company will have expanded innovation capabilities in small molecule design, biologics/synthetic biologics, protein homeostasis, antibody engineering and cell therapy. Furthermore, strong external partnerships provide access to additional modalities. "Together with Celgene, we are creating an innovative biopharma leader, with leading franchises and a deep and broad pipeline that will drive sustainable growth and deliver new options for patients across a range of serious diseases," said Giovanni Caforio, M.D., Chairman and Chief Executive Officer of Bristol-Myers Squibb. "As a combined entity, we will enhance our leadership positions across our portfolio, including in cancer and immunology and inflammation. We will also benefit from an expanded early- and late-stage pipeline that includes six expected near-term product launches. Together, our pipeline holds significant promise for patients, allowing us to accelerate new options through a broader range of cutting-edge technologies and discovery platforms."

AstraZeneca PLC (NYSE: AZN) has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients' lives and the Company's future. AstraZeneca recently announced a new multi-term agreement with Innate Pharma (Innate), building on an existing collaboration, aimed at accelerating each company's oncology portfolio and bringing new medicines to patients more quickly. The extended collaboration will enrich AstraZeneca's immuno-oncology (IO) portfolio with pre-clinical and clinical potential new medicines. AstraZeneca will obtain full oncology rights to the first-in-class humanized anti-NKG2A antibody, monalizumab, expanding its partnership with Innate from the initial collaboration announced in 2015. AstraZeneca also gains option rights to IPH5201, an antibody targeting CD39, as well as four preclinical molecules from Innate's pipeline. Innate is licensing the US and EU commercial rights to recently FDA-approved Lumoxiti (moxetumomab pasudotox) for hairy cell leukaemia (HCL). Pascal Soriot, Chief Executive Officer, said: "Our expanded collaboration with Innate Pharma enables us to further strengthen our leadership in immuno-oncology, and to explore the potential of next-generation immuno-oncology pathways, together with the world-class scientific team of Innate. Today's agreement also secures the long-term commercialisation of the recently FDA approved rare disease medicine, Lumoxiti, through dedicated focus and investment by Innate Pharma."

Nektar Therapeutics (NASDAQ: NKTR) is a research-based development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Nektar Therapeutics recently announced a presentation of new clinical data for bempegaldesleukin1 (NKTR-214) in combination with nivolumab in patients with first-line (1L) advanced or metastatic urothelial carcinoma at the 2019 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium(GU) in San Francisco, CA. Bempegaldesleukin is an investigational, first-in-class, CD-122-preferential IL-2 pathway agonist designed to provide rapid activation and proliferation of cancer-killing immune cells, known as CD8+ effector T cells and natural killer (NK) cells, without over activating the immune system. Bempegaldesleukin has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines. "Preliminary data from the ongoing PIVOT-02 trial in metastatic urothelial cancer patients demonstrated important response rates, including complete responses, in patients who were cisplatin-ineligible or refused standard of care," said Mary Tagliaferri, M.D., Chief Medical Officer of Nektar Therapeutics. "These responses were observed regardless of baseline PD-L1 expression and no relapses occurred. In this cohort of Stage IV bladder cancer patients with a median age of 70, the combination therapy was generally well tolerated with no Grade 4 or 5 adverse events reported. Of note, our translational research demonstrated that in patients with the highest unmet medical need – those whose tumors did not express PD-L1 at their baseline scan – treatment with the combination resulted in 70 percent of patients converting to PD-L1 positive expressors. These data support our development strategy in this tumor setting, including the Phase 2 PIVOT-10 study underway in cisplatin-ineligible urothelial cancer patients with low PD-L1 tumor expression."

Immunomedics, Inc. (NASDAQ: IMMU) is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Immunomedics, Inc. and Samsung BioLogics Co., Ltd. recently announced that the companies have entered into a long-term manufacturing partnership agreement under which Samsung will manufacture Immunomedics' proprietary humanized antibody, hRS7, at its manufacturing facilities in Incheon, South Korea. Technology transfer and engineering runs for the new antibody production are currently underway, with commercial production expected to begin in 2020, subject to regulatory approval. "This agreement is an important part of our overall strategy to further enhance our supply chain and continue to improve our cost-structure," said Dr. Morris Rosenberg, Chief Technology Officer of Immunomedics. "We look forward to working closely with Samsung BioLogics, a world-renowned contract manufacturer, to ensure we have sufficient long-term supply of our lead antibody-drug conjugate, sacituzumab govitecan, as we advance it into additional patient segments and earlier lines of breast and urothelial cancers, as well as broadening into other cancer indications and expanding the company's ex-US geographic footprint."

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